Rsch Regulatory Analyst III - University of Florida

Gainesville, FL

About the Job

This is a highly professional and responsible position, which answers directly to the Asst. Director of IRB Services.This employee is expected to use his/her knowledge of IRB requirements to assist investigators with the submission and management of their IRB related paperwork. This employee is also expected to collaborate with other IRB staff for the compliant and efficient processing of new studies (including reviewing research for HIPAA requirements).

Classification Title:	Research Regulatory Analyst III
Job Description:	Review of IRB submissions (expedited and full board) Review of IRB submissions (new submissions, modifications) to evaluate proposal content and compliance with Federal, and State regulations, and UF policies. Assisting investigators in preparing protocols for IRB review, including recommending changes and communicating outcome of review. -Coordinate with PIs and reviewers to identify and (resources permitting) help resolve issues in research relating to Federal Regulations, IRB policies, and other regulatory requirements or compliance needs to facilitate effective IRB review and approval of research protocols; -Intra and inter office communication, including listserv to address researcher needs and inquiries about the IRB matters, including myIRB assistance, ICF and protocol assistance. Review and approve research that meets exempt, nonhuman, or indefinite plans criteria. Special focus on chart reviews. Serve on the IRB-01 committee and perform executive privacy reviewer function for chart reviews that require privacy review. Understanding and dissemination information about HIPAA regulations as they apply to research and as applied to evaluating secondary research. Serve as IRB’s administrative expert in HIPAA for pre- and post-review of research; stay informed on any upcoming changes to HIPAA; assist in developing IRB policies to ensure HIPAA compliance; liaison with the UF Privacy Office and other research compliance offices; Liaison with Investigators and their staff and affiliated research compliance personnel. Educating research teams one-on-one, in small groups and in formal classes on ethical guidelines and federal regulations pertaining to human subjects’ protection, Guidelines for Good Clinical Practice, and IRB/Institutional policies and procedures. Other responsibilities: Assist IRB Asso. Director and other IRB staff with policies and procedures development, full board support, AARPP accreditation, and international ancillary review.
Expected Salary:	Commensurate with experience and expertise
Minimum Requirements:	Master's degree in an appropriate area and one year of relevant experience; or a bachelor's degree in an appropriate area and three years of relevant experience;or an equivalent combination of education and experience.
Preferred Qualifications:	College work in science and/or research and familiarity with medical terminology. Strongly prefer individuals with prior experience working as a research coordinator engaged in human research. Prefer individuals with (a) prior experience in human subjects research or research compliance; (b) working knowledge of human research protection related regulations, laws, and institutional policies; (c) ability to act as liaison and to use negotiation skills to assist investigators with processing their protocols. The selected candidate must possess excellent written and oral communication skills.
Special Instructions to Applicants:	In order to be considered, you must upload your cover letter, resume and a list of three professional references. A criminal background check is required. This is not a remote work position, and it is located on the University of Florida main campus in Gainesville, FL. Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:	No.

Source : University of Florida